Recognized Consensus Standards: Medical Devices
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Date of
Entry |
Specialty Task
Group Area |
Recognition
Number |
Extent of
Recognition |
Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
07/06/2020 | Biocompatibility | 2-276 | Partial | ISO | 10993-18 Second edition 2020-01 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process. |
05/29/2023 | Cardiovascular | 3-188 | Partial | ISO | 81060-3 First edition 2022-12 | Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type |
05/29/2023 | ObGyn/ Gastroenterology/ Urology |
9-143 | Partial | ISO | 20696 First edition 2018-06; Corrected 2019-12 | Sterile urethral catheters for single use |
05/29/2024 | General II (ES/ EMC) |
19-50 | Partial | IEC | TS 60601-4-2 Edition 1.0 2024-03 | Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
05/29/2023 | InVitro Diagnostics | 7-317 | Partial | CLSI | M100, 33rd Edition | Performance Standards for Antimicrobial Susceptibility Testing |
12/20/2021 | General Plastic Surgery/ General Hospital |
6-474 | Partial | ASTM | F3352-19 | Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
12/23/2019 | Cardiovascular | 3-163 | Partial | ISO | 18242 First edition 2016-09-01 | Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps |
05/29/2024 | Ophthalmic | 10-135 | Partial | ISO | 11979-7 Fifth edition 2024-01 | Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia |
07/15/2019 | Ophthalmic | 10-116 | Partial | ANSI | Z80.35-2018 (R2023) | American National Standard for Ophthalmics - Extended Depth of Focus Intraocular Lenses |
12/20/2021 | Biocompatibility | 2-294 | Partial | USP-NF | M98834_01_01 | <88> Biological Reactivity Tests, In Vivo |